OncoMatch/Clinical Trials/NCT03323346
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Is NCT03323346 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Disulfiram for breast neoplasm female.
Treatment: Disulfiram — The aim of the study is to establish clinical evidence for introducing disulfiram and cooper as an active therapy for metastatic breast cancer upon failure of conventional systemic and/or locoregional therapies. Analyses of the following objectives will be performed in the population of patients with metastatic breast cancer: Primary efficacy objective: To evaluate the efficacy of the treatment by assessment of: * clinical response rate (RR) * clinical benefit rate (CBR) Secondary efficacy objectives: To evaluate the efficacy of the treatment by assessment of: * time to progression (TTP) * overall survival (OS) Pharmacokinetic objectives: • to determine pharmacokinetic parameters for disulfiram and its active metabolites administered in combination with copper supplements in cancer patient population Safety objectives: • to describe safety profile of disulfiram administered in combination with copper supplements Exploratory objectives: Parallel analysis to assess (identify) potential candidate surrogate biomarkers of disulfiram efficacy, as well as identification (using proteomic, biochemical and molecular genetic studies) of potential predictive biomarkers of disulfiram sensitivity or resistance will be performed. Surrogate biomarker analysis will focus on in vivo ubiquitin-proteosomal system inhibition, cell cycle and DNA damage.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapeutic modalities
Patients have failed, untolerated or refused standard therapeutic modalities
Cannot have received: systemic anticancer therapy
Exception: not received in last 2 weeks
Not received systemic anticancer therapy or radiation or had major surgery in last 2 weeks
Cannot have received: cytotoxic cancer chemotherapy agents
Actively receiving cytotoxic cancer chemotherapy agents
Lab requirements
Liver function
Baseline AST and ALT not greater than 2.5 X upper institutional limit
Baseline AST and ALT not greater than 2.5 X upper institutional limit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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